|Author (Corporate)||Council of the European Union, European Parliament|
|Series Title||Official Journal of the European Union|
|Series Details||L 20, Pages 1-37|
|Content Type||Blog & Commentary, Legislation, News, Policy-making|
Regulation (EU) 2022/123 - formally signed by the co-legislators on 25 January 2022 - aimed at reinforcing the mandate of the European Medicines Agency (EMA) when it comes to crisis preparedness and management for medicinal products and medical devices. This is a text with EEA relevance.
The COVID-19 (coronavirus) pandemic highlighted the limited ability of the European Union (EU) to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development. It became clear that the EMA requires a framework to be deployed in preparation for and during public health emergencies and other major events to improve the EU's capacity to react quickly, efficiently, and in a coordinated manner to such emergencies. The general objectives of the legislative proposal are to:
It was tabled by the European Commission on 11 November 2020, alongside a Communication setting out the first elements of a European Health Union. The Council of the European Union adopted its general approach on 15 June 2021, followed by the plenary of the European Parliament on 8 July. An informal agreement between the co-legislators on a compromise text was reached on 28 October. This was endorsed by the Parliament on 20 January 2022 and by the Council on 25 January. The Act was signed by the co-legislators on that same day and published in the Official Journal on 31 January 2022.
|Subject Tags||Public Health|
|International Organisations||European Union [EU]|